Nowadays medical devices like for example insulin pumps get smaller and smaller. As a result the controls of such a small medical device may get too small to be used manually by a patient. Therefore in some cases it is useful to control these medical devices using a separate device like for example a mobile device, which is connected to the medical device. For example medical devices can nowadays be controlled using a smartphone. However, as medical devices may perform life critical actions like applying a medication to a patient, it may be necessary to supervise the execution of the medical app running on a smartphone as smartphones in general are not developed in accordance with medical safety guidelines like IEC 62304.
An infusion pump is a medical device that delivers fluids, such as nutrients and medications, into a patient's body in controlled amounts. Infusion pumps are in widespread use in clinical settings such as hospitals, nursing homes, and in the home.
In general, an infusion pump is operated by a trained user, who programs the rate and duration of fluid delivery through a built-in software interface. Infusion pumps offer significant advantages over manual administration of fluids, including the ability to deliver fluids in very small volumes, and the ability to deliver fluids at precisely programmed rates or automated intervals. They can deliver nutrients or medications, such as insulin or other hormones, antibiotics, chemotherapy drugs, and pain relievers.
There are many types of infusion pumps, including large volume, patient-controlled analgesia (PCA), elastomeric, syringe, enteral, and insulin pumps. Some are designed mainly for stationary use at a patient's bedside. Others, called ambulatory infusion pumps, are designed to be portable or wearable.
Because infusion pumps are frequently used to administer critical fluids, including high-risk medications, pump failures can have significant implications for patient safety. Many infusion pumps are equipped with safety features, such as alarms or other operator alerts that are intended to activate in the event of a problem. For example, some pumps are designed to alert users when air or another blockage is detected in the tubing that delivers fluid to the patient. Some newer infusion pumps, often called smart pumps, are designed to alert the user when there is a risk of an adverse drug interaction, or when the user sets the pump's parameters outside of specified safety limits.
Insulin pump therapy is often referred to as “Continuous Subcutaneous Insulin Infusion” (CSII) and closely imitates the natural action of the pancreas, providing a constant supply of insulin to the body and extra doses as needed.
When using a portable insulin pump, there is no longer any need for injections. Instead the pump is controlled to continuously supply a patient's body with the insulin it requires by way of a subcutaneous cannula (under the skin).
One approach for controlling the program flow of a computer program is known as “COMEFROM” programming. In this case the individual sub-processes of a computer program hand over intermediate results of the execution of the sub-process to a subsequent process wherein the addressed process may then verify whether the process calling is actually allowed to call the subsequent process. As a result the whole execution of a computer program is controlled by the individual modules of the computer program verifying if they are activated in the correct order. As soon as there is not only one sequence of processes involved but more than one, wherein the individual processes of both sequences affect each other, the COMEFROM from approach will not work anymore as there is usually no communication between the modules of the individual sequences. As it may further be possible that some processes of a first sequence of processes may only be executed if a series of individual process of another sequence of processes have already been executed, the COMEFROM approach is not sufficient anymore.